Kornimate/medical-research-clean huggingface dataset:
promoting home smoking restrictions: biomarker feedback to smoking and non-smoking adults

Conditions: Smoking Cessation; Tobacco Use Disorder

Summary: this study is directed at decreasing home environmental tobacco smoking (ets) exposure with a novel approach of adoption of home smoking restrictions. this will be done by providing the cohabitating smoker and non-smoker with biomarker feedback documenting exposure to ets. the intent is to identify an intervention strategy(ies) to reduce ets exposure.

this is a two-group interventional trial targeting cohabitating smokers and non-smokers. participants will be randomized to the control condition or biomarker feedback group.

Eligibility criteria:
inclusion criteria: * must be at least 18 years of age * cohabitating non-smoker (control) and smoker (active) * smoker must test \> 6ppm on carbon dioxide (co) test and non-smoker \< 6ppm * general good health * written informed consent * live within twin cities 7 county metropolitan area (minnesota) * plan to live in same home for 6 months and be willing for researchers to come to their home exclusion criteria: * individuals that live in a treatment facility or shelter * individuals endorsing current domestic violence

Keywords: tobacco cessation
new options for preoperative anesthesia in intrauterine needling

Conditions: Stress; Pain

Summary: the concept of fetal pain is becoming increasingly relevant due to growing possibilities for invasive intrauterine treatment. there is much debate as to whether the fetus is mature enough to be able to perceive pain at all. recent studies have suggested that the fetus is at least capable of exhibiting a stress response to intrauterine needling. intrauterine transfusions are most commonly performed by inserting a needle either in the umbilical cord root at the placental surface, or in the intrahepatic portion of the umbilical vein of the fetus. recently, intrauterine needling in the intrahepatic vein has been shown to result in alterations in fetal stress hormones, which has been interpreted as a reaction to pain. these changes were not observed in intrauterine needling in the umbilical cord root, or after administration of analgesics to the fetus. the investigators tested the hypothesis that remifentanil provides fetal analgesia, assessed by a reduced fetal stress response. the investigators performed a randomised controlled trial comparing fetal stress response between patients undergoing intrauterine transfusions for alloimmune fetal anemia receiving remifentanil, or placebo.


Eligibility criteria:
inclusion criteria: * singleton pregnancy * clinically indicated intrauterine transfusion * red cell alloimmunisation exclusion criteria: * severe adipositas * suspicion of structural anomalies * fetal hydrops * contraindication for remifentanil

Keywords: fetal pain intrauterine needling
comparing nifedipine and enalapril in medical resources used in the postpartum period

Conditions: Hypertension in Pregnancy; Preeclampsia Severe; Gestational Hypertension; Postpartum Preeclampsia; Postpartum

Summary: this study evaluates whether nifedipine or enalapril is better at decreasing the amount of medical resources used in the postpartum period by women who have high blood pressure in pregnancy and the postpartum period. half of participants will receive enalapril while the other half will receive enalapril. we will compare the two groups in the amount of medical resources used which we are defining as prolonged hospitalizations, unscheduled medical visits and/or hospital readmissions in the postpartum period.

this is randomized controlled trial to investigate if enalapril is superior to nifedipine in terms of medical resources used in postpartum women with hypertension. these are both antihypertensives we commonly use in the postpartum period for women with hypertension in pregnancy but we do not know which medication works better at decreasing prolonged hospitalizations, the number of unscheduled medical visits and/or readmissions to the hospital. nifedipine is more traditionally used and well-validated by current medical literature. however, enalapril's mechanism of action is better suited to the dysregulation of blood pressure that can occur with hypertensive disorders of pregnancy. therefore, we hypothesize that enalapril is superior to nifedipine in terms of medical resources used in the postpartum period.

Eligibility criteria:
inclusion criteria: * diagnosis of any hypertensive disorder of pregnancy/postpartum period or chronic hypertension * provider wanting to initiate antihypertensive in the postpartum period * the patient is not currently on \>1 antihypertensive * plans to receive postpartum care at the hospital or affiliated clinic exclusion criteria: * sustained pulse \ 120 bpm over four hours * allergy to any of the antihypertensives * creatinine greater than or equal to 1.5 * strict contraindication to any of the antihypertensives * history of failed treatment with any of the antihypertensives
a study of the safety and clinical effects of interferon gamma-1b in patients with idiopathic pulmonary fibrosis (ipf)

Conditions: Idiopathic Pulmonary Fibrosis

Summary: study gipf-002 is a phase 2 study designed to characterize the biologic and clinical effects of ifn-g 1b. the objective of the study is to characterize the biologic and clinical effects of ifn-g 1b administered to patients with idiopathic pulmonary fibrosis (ipf). the study will be conducted at multiple sites and enroll 30 patients with ipf who have failed treatment with corticosteroids.


Eligibility criteria:
male or female 20-79 years old
pharmacokinetics & tolerability study of map0004 co-administered with ketoconazole

Conditions: Healthy

Summary: compare the dhe pharmacokinetic profiles observed following administration of: 1. map0004 (oral inhalation dhe) 2. map0004 co-administered with oral ketoconazole 3. intravenous (iv) dhe (d.h.e.45®, the approved reference therapy) compare the tolerability of map0004, iv dhe, and map0004 with co-administration of ketoconazole.


Eligibility criteria:
major inclusion criteria: * able to provide written informed consent * male or female subjects 18 to 45 years old * female subjects who are practicing adequate contraception or who are sterile * stable cardiac status * normal rhythm or arrhythmia deemed clinically insignificant on ecg exclusion criteria: * contraindication to dihydroergotamine mesylate (dhe) * use of any excluded concomitant medications within the 10 days prior to visit 1 * history of hemiplegic or basilar migraine * participation in another investigational trial during the 12 weeks prior to visit 1 or during this trial

Keywords: drug drug interaction study in normal healthy volunteers
fred/ fred jr/ fred x intracranial aneurysm treatment study

Conditions: Intracranial Aneurysm

Summary: a prospective, multicenter, observational evaluation of the safety and efficacy of the fred® device in the treatment of intracranial aneurysms

this is a multi-center observational study. treatment and follow-up visits will be performed as per standard of care. the purpose of this study is to demonstrate that use of the fred/ fred jr/ fred x embolic device in intracranial aneurysm treatment is safe and effective when assessed at 6, 12 months and yearly up to 5 years post procedure. 150 patients will be enrolled over an 15-month recruitment period. all patients will be followed for 5 years.

Eligibility criteria:
inclusion criteria: 1. patient older than 18 years old 2. patient harboring a non-acutely ruptured intracranial aneurysm within the last 30 days of presentation: * for which use of fred, fred jr or fred x has been deemed appropriate * being the only aneurysm to require treatment within the next 12 months * and optionally previously treated by surgery (clipping) or with an intrasaccular device: aneurysm recanalized 3. patient with a modified rankin scale (mrs) ≤ 2 4. patient has received information about data collection and has signed and dated an informed consent form exclusion criteria: 1. patient has suffered from an ich within the 30 days prior to the procedure. 2. the aneurysm to be treated is associated with a cavm 3. the aneurysm to be treated is in the posterior circulation 4. the aneurysm to be treated has a stenosis of its parent artery \>50% 5. patient has another aneurysm previously treated with a stent or a flow diverter * on the same parent vessel at any time * on a different parent vessel, less than 3 months prior to the procedure (previously-implanted stents in the non-index proximal carotid are acceptable) 6. patient with whom anticoagulant, antiplatelet or thrombolytic drugs are contra-indicated or test performed regarding ap medication administered is not efficient for the patient 7. patient with known hypersensitivity to contrast products or nickel titanium, not treatable 8. pregnancy or child breastfeeding 9. patient unable or unlikely to complete required follow up 10. patient has severe or fatal comorbidity or a life expectancy of less than 1 year 11. treatment with a flow diverter other than fred/ fred jr/ fred x or in addition to fred/ fred jr/ fred x is planned
mental health promotion interventions among migrant workers in china

Conditions: Depression; Anxiety

Summary: the goals of this research were to conduct a mental health intervention study for reducing self-reported depression and anxiety among migrant workers in a labor-intensive industry in china and to assess the effectiveness of the integrated mental health interventions aimed at promoting the mental health of migrant workers in labor-intensive industries in china.


Eligibility criteria:
inclusion criteria: * people who worked in the factory agreed to take participant in this study and could understand the questionnaire. exclusion criteria: * people who don't want to take participant in the study; people can not understand the questionnaire.

Keywords: mental health promotion depression migrant workers china
cesarean section scar niche: the impact on assisted reproductive technology outcome

Conditions: Cesarean Section Niche Impact on ART

Summary: the presence of cesarean section niche has adverse effects on success of art outcome

a common finding by ultrasound in secondary infertility patients with previous cesarean sections is the presence of niche, which is formally defined as an indentation of the uterine myometrium of at least 2 mm at the site of the caesarean scar. the most common symptom of niche is abnormal uterine bleeding, other symptoms include dysmenorrhea, chronic pelvic pain, dyspareunia, and sub-fertility/infertility. it has been reported that a niche can reduce the chances of embryo implantation and may lead to spontaneous miscarriages if the implantation is close to or in the niche. the presence of a niche may render the actual embryo transfer procedure technically more difficult, and clinicians need to be aware of its presence and perform the transfer under ultrasound guidance to ensure the catheter bypasses the niche and enters the uterine cavity. still the impact of c.s niche and its characteristics on outcome of art is not clear.

Eligibility criteria:
inclusion criteria: * all women should have the following: * aged from 18 - 37 years old. * undergoing fresh icsi cycles. * a normal uterus with no anomalies or pathologies. * at least one good-quality embryo/blastocyst available for transfer (3 bb and more according to gardner and schoolcraft grading system). * easy mockup embryo transfer (i.e. the catheter is smoothly inserted without touching the fundus, no cervix tenaculum is used and the catheter is clean of blood). exclusion criteria: * younger than 18 or older than 37 years old. * congenital uterine abnormality or pathology. * presence of a hydrosalpinx. * chronic diseases which are not suitable for pregnancy. * icsi cycles with fresh or frozen tese samples.

Keywords: cesarean section niche
vitamin d pilot study in patients with multiple sclerosis

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: phase 1 study of 19-nor vitamin d in relapsing-remitting ms. primary measure is mri.


Eligibility criteria:
inclusion criteria: * relapsing remitting ms exclusion criteria: * mri contraindicated

Keywords: vitamin d, 19 nor vitamin d, multiple sclerosis
diabetic foot ulcers-comparing transforming powder to standard of care

Conditions: Diabetic Foot Ulcer

Summary: phase iv, randomized, prospective, multi-center, open-label, comparison of transforming powder dressing to standard of care dressing for healing diabetic foot ulcers.

diabetic men and women aged 18-89 years, who have a diabetic foot ulcer present for a minimum of 30 days will be considered for the study. subjects will be randomized to either standard of care wound dressings or transforming powder dressing. half of the subjects will receive standard of care dressings, and the other half will receive transforming powder dressing in a 1:1 randomization process at each of the study sites. subjects will present to the study center weekly for up to 12 weeks (less time if the wound heals prior to 12 weeks). the last study visit occurs 12 weeks after the end of study visit.

Eligibility criteria:
inclusion criteria: * 18-89 years old * diagnosed with diabetes mellitus; hemoglobin a1c \< 12% * diabetic foot ulcer present for minimum 30 days (wagner grade 1 or 2 classification) * wound drainage is minimal or moderate * no clinically active wound infection * able and willing to provide consent * has not participated in another research trial within 3 months of enrollment. exclusion criteria: * unable to keep weekly research appointments * unable or unwilling to use offloading device if recommended * wounds with large amount (high) drainage * active gangrene * wounds impending surgical intervention (including revascularization or plastic surgery) * untreated osteomyelitis * soft tissue infection (can be enrolled once infection is cleared) * active charcot arthropathy * bmi \>45kg/m2 * history of aids * history of organ transplant or impending transplant * end stage renal disease requiring dialysis * decompensated hepatic or cardiac disease * select autoimmune diseases * lymphedema * oral steroid use in last 3 months * venous stasis disease * active malignancy (cancer) * unable to sign consent * active alcohol or substance abuse * pregnant or lactating women * insufficient vascular flow to heal a wound * hemoglobin a1c \>12%

Keywords: standard of care wound dressings transforming powder dressing diabetic foot ulcers altrazeal
effects of o2 and/or co2 inhalation on rest and exercise pulmonary hemodynamic

Conditions: Pulmonary Vascular Sensibility in Hypoxia; Hypercapnia; Hypoxia and Hypercapnia

Summary: the aim of this study is to describe the pulmonary hemodynamic evolution at rest and during a short constant load exercise in 4 conditions : * normoxia * hypoxia * hypercapnia * association hypoxia and hypercapnia


Eligibility criteria:
inclusion criteria: * healthy male * exercise capacity between 100 and 130 % of theorical values exclusion criteria: * smoker * headache * impossibility to perform an exercise test * no tricuspid regurgitation on the echocardiography
sarcopenia measured by ultrasound in hospitalized older adults

Conditions: Sarcopenia

Summary: observational prospective study in older adults admitted to an acute geriatric unit, in which sarcopenia will be evaluated by ultrasound in the anterior rectus femoris muscle.

the main objective of the study is to estimate, by means of portable ultrasound, parameters of muscle quantity and quality (anterior rectus femoris muscle area, width and echostructure ) in older adults hospitalized in acute geriatric units for medical reasons.

Eligibility criteria:
inclusion criteria: * patients over 69 years of age. * hospitalization for a medical cause in acute geriatric units. * holden's functional ambulation classification scale at level 1 or higher. * informed consent signed by the patient or legal representative. exclusion criteria: * terminal condition or life expectancy of less than 6 months. * impossibility or refusal to undergo muscle ultrasound. * refusal for follow-up * severe dementia stage global deteriorating scale: 7 * impossibility in the opinion of the investigators to complete the necessary data for the study.

Keywords: sarcopenia ultrasound aged hospitalized
thrombogenic factors and recurrent coronary events

Conditions: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Myocardial Infarction; Thrombosis; Death, Sudden, Cardiac

Summary: to determine if selected circulating blood factors that reflect enhanced thrombogenesis are associated with an increased incidence of recurrent coronary events, including cardiac death or non-fatal myocardial infarction.

design narrative: in this multicenter, collaborative, prospective study, patients hospitalized with a myocardial infarction were enrolled from ten geographically dispersed centers. five thrombogenic- related blood factors were quantitated, and formed the centerpiece of this study: 1) lipoprotein(a) \[lp(a)\] - a quantitative genetic factor that contains apolipoprotein b, has a structural homology to plasminogen, interferes with intrinsic thrombolytic activity, and represents a crossover link in the thrombogenesis/atherogenesis hypothesis; 2) soluble fibrin - a system indicator of coagulation activity in the ongoing conversion of fibrinogen to insoluble fibrin strands; 3) plasminogen activator inhibitor-1 (pai-1) - an important regulator of the fibrinolytic system, it interferes with intrinsic t-pa activity; 4) coagulation factor vii -high levels lead to increased thrombogenesis and have been associated with an increased risk of ischemic heart disease; and- 5) von willebrand factor - it binds to platelet glycoproteins, contributes to local thrombus formation, and it is elevated in patients at increased risk of coronary thrombosis. the primary analysis utilized a time-dependent survivors hip model (cox regression) to determine the presence or absence of an association between one or more of these factors and subsequent thrombotic-related coronary events. secondary objectives included: 1) to determine if there was a statistical association between the thrombogenic factors and conventional hematologic/lipid parameters, and to evaluate their interactions regarding coronary events; and 2) to determine if thrombogenic factors had uniform effects on coronary event rates across various subgroups.

Eligibility criteria:
no eligibility criteria
20-year implant survival in periodontally healthy and compromised patients

Conditions: Dental Implant Failed; Peri-Implantitis; Bone Loss

Summary: the aim of this study will be to compare the long-term outcomes of sandblasted and acid-etched (sla) implants in patients previously treated for periodontitis and in periodontally healthy patients (php) after a follow-up of at least 20-years.


Eligibility criteria:
inclusion criteria: * complete edentulism; * presence of an implant-supported overdenture; * mucosal diseases; * alcohol and drug abuse; * pregnancy; * uncontrolled metabolic disorders; * aggressive periodontitis; * no interest in participating in the study exclusion criteria: * everything not as inclusion criteria
aids wasting in women: anabolic effects of testosterone

Conditions: AIDS Wasting Syndrome

Summary: the study is a 6 month, placebo-controlled study of transdermal testosterone for women with hiv-associated weight loss. women with aids wasting have been found to have low testosterone levels. this study is designed to test the efficacy of physiologic testosterone dosing to improve weight, muscle mass and quality of life indices, including energy level, appetite and libido, in androgen deficient women with aids wasting. after 6 months, all women receive open label transdermal testosterone for an additional 6 months.


Eligibility criteria:
inclusion criteria: * females using acceptable form of birth control during study, including barrier contraception or iud but excluding oral contraceptives or depo-provera * documented hiv infection * free testosterone level 3.0 pg/ml * weight \ 10% of pre-illness weight exclusion criteria: * pregnant or actively seeking pregnancy * breast feeding * new opportunistic infection diagnosed within 4 weeks of the study * requiring parenteral nutrition or pharmacologic glucocorticoid therapy * intractable diarrhea (6 stools/day) * androgen, estrogen, progestational derivative, or glucocorticoid administration within 3 months of the study, including megace * new retroviral therapy within 6 weeks of study * sgot \> 5 x normal and/or clinically significant liver disease * creatinine \> 2.0 mg/dl and/or clinically significant renal disease * hgb \< 8.0 g/dl * active substance abuse or alcoholism

Keywords: aids hiv weight loss wasting syndrome testosterone androgen levels hormones
thra_hematologic variables

Conditions: Avascular Necrosis of Hip

Summary: total hip replacement arthroplasty is a surgery having intra- and postoperative substantial blood loss. the investigators will investigate the relationship between the various hematologic variables and postoperative bleeding volume.


Eligibility criteria:
inclusion criteria: * avascular necrosis of hip * total hip replacement arthroplasty exclusion criteria: * revision operation * hematologic disease * anticoagulant medication * preoperative hemoglobin \< 10 g/dl * preoperative transfusion of red blood cells
cryocompression to reduce chemotherapy-induced peripheral neuropathy in gynecologic cancer - cohort 2

Conditions: Gynecologic Cancer; Chemotherapy-induced Peripheral Neuropathy

Summary: the investigators aim to determine the effect of cryotherapy wraps plus compression therapy (henceforth referred to as cryocompression) versus cryotherapy wraps alone on the incidence and degree of chemotherapy-induced peripheral neuropathy in patients with gynecologic cancer using a noninferiority design. the investigators also aim to determine the effect of cryocompression versus cryotherapy on patient tolerability and patient and staff satisfaction.

participants will be randomized by patient to receive cryotherapy wraps plus compression therapy (cryocompression) versus cryotherapy wraps alone applied to the bilateral hands and feet. participants will receive cryotherapy (+/- compression) for the duration of their taxane infusions. participants will be asked to complete the fact-ntx survey and a pnq neuropathy surveys at each infusion visit to evaluate symptoms related to neuropathy. participants will also complete a brief acceptability and tolerability survey at each visit. lastly, a staff satisfaction survey will be administered at each visit as well. the investigators will test the hypothesis that the average final visit fact-ntx11 scores in the cryotherapy group are noninferior to the cryocompression group with a noninferiority margin of 2.5 points. the investigators will routinely monitor for the following adverse events: frost bite, (unexpected) hospitalizations, and death.

Eligibility criteria:
inclusion criteria: * gynecologic cancer diagnosis (ovarian, cervical, endometrial cancer; adenocarcinomas of likely primary gynecologic origin based on cytology or fna in conjunction with radiologic impression will be eligible) * plan to receive at least 6 cycles of paclitaxel administered every 3 weeks at the duke cancer center or macon pond or at the carilion clinic in roanoke, va. patients receiving neoadjuvant chemotherapy with a plan for interval debulking will be eligible. * ecog (eastern cooperative oncology group) performance status of 0-1 exclusion criteria: * treated with prior neurotoxic chemotherapeutic agents * baseline diagnosis of peripheral neuropathy such as diabetic neuropathy, or conditions including but not limited to fibromyalgia, cryoglobulinemia and raynaud's disease.